Treatment of Refractory Gout With ACTH or Methylprednisolone

Last updated: March 19, 2021
Sponsor: Shanghai 10th People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Musculoskeletal Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04808856
ACTH
  • Ages > 18
  • All Genders

Study Summary

To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (123 items and 1 item from 4-7 are met simultaneously) :
  1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout
  2. Acute gouty arthritis
  3. Age ≥18
  4. Repeated attacks and prolonged pain (more than 1 month);
  5. poor response or intolerance to colchicine or NSAIDs;
  6. Liver and kidney dysfunction;
  7. Old age;

Exclusion

Exclusion Criteria:

    1. History of gastrointestinal bleeding and active ulcer 2) The application history ofglucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4)Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6)Mental illness inability to communicate or have language barriers and inability tofully understand and cooperate 7) negligent compensatory heart failure, unstableangina pectoris, stroke, transient ischemic attack, myocardial infarction, and severearrhythmia occurred within 6 months 8) The investigator did not consider itappropriate to participate in the study

Study Design

Total Participants: 60
Study Start date:
April 01, 2021
Estimated Completion Date:
April 01, 2022

Study Description

When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .

Connect with a study center

  • Shanghai Tenth People's hospital

    Shanghai, Shanghai 200070
    China

    Active - Recruiting

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